Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jane Hicks

ORCID ID

Contact details

Cottham House
Cottham Hill
Bristol
BS16 1JB
United Kingdom
+44 (0)117 9 427 373

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0038104044

Study information

Scientific title

Acronym

Study hypothesis

Does nefazodone improve sleep in insomnia?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders: Insomnia

Intervention

1. Nefazodone
2. Placebo

This is a double blind placebo-controlled crossover study to look at the effects of nefazodone on sleep in insomnia. Patients will be given a two week washout from any psychotropic medication and then randomised to take either 100 mg of nefazodone or placebo for 2 weeks with a 2 week washout, then cross over to the treatment. At the end of the each 2 weeks their overnight sleep will be measured at home by polysomnography and they will be asked to fill in questionnaires about their sleep. Objective and subjective sleep measures will be compared in subject between the two treatment periods.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Objective Total Sleep Time
2. Subjective Sleep Quality

Secondary outcome measures

All other measures of objective and subjective sleep

Overall trial start date

01/10/2001

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 18 to 65 meeting criteria for insomnia (International Classification of Sleep Disorders) and without: use of other psychotropic drugs, allergy to nefazodone, current or past severe mental illness or substance abuse, current depressive illness.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2001

Recruitment end date

30/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cottham House
Bristol
BS16 1JB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Avon and Wiltshire Mental Health Partnership NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21699717

Publication citations

  1. Protocol

    French DP, Williams SL, Michie S, Taylor C, Szczepura A, Stallard N, Dale J, A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: study protocol., BMC Fam Pract, 2011, 12, 56, doi: 10.1186/1471-2296-12-56.

Additional files

Editorial Notes